Monica Kraft, MD: Discussing Phase 3b Findings on Albuterol/Budesonide for Asthma

At the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, new late-breaking data from AstraZeneca were presented from the phase 3b BATURA study. The study represented the company’s first fully decentralized trial for asthma.

The findings showed that albuterol/budesonide (Airsupra), an inhaled anti-inflammatory rescue treatment, met its primary endpoint and diminished subjects’ risk of severe exacerbations for those with intermittent or mild persistent asthma. To discuss the results, the HCPLive team interviewed Monica Kraft, MD, the Murray M. Rosenberg Professor of Medicine and System Chair for the Mount Sinai Health System department of medicine.

“There's a large portion of individuals with asthma who use albuterol alone out there, and that is something we have been very much trying to rectify over the years, because we now know asthma is an inflammatory lung disease needing anti-inflammatory therapy,” Kraft said. “I think there was a time when the guidelines stated ‘if you just use that albuterol once or twice-a-week, you don’t really need anti-inflammatory therapy.’ The tide has shifted to more of a preventative mode, as we know that we want to prevent exacerbations.”

The BATURA study was a randomized, double-blind, parallel-group, event-driven analysis designed to compare the safety and effectiveness of inhaled albuterol/budesonide (180mcg/160mcg) use as an as-needed rescue medication in response to asthma symptoms versus as-needed albuterol (180mcg), all up to a year. Those recruited for the study were aged 12 years and over with intermittent or mild persistent asthma.

Kraft commented that the idea of the study had been to compare the albuterol/budesonide versus albuterol alone, and then albuterol/budesonide versus ICS/LABA along with albuterol.

“So what was interesting is that the mild group didn't exacerbate that frequently,” Kraft said. “It's about 12%, which isn't all that much. But despite that, there was still a 47% reduction in exacerbations with Airsupra in the albuterol arm, which is impressive. Overall, there was actually…In the albuterol group, they went from 65%, so the majority of the patients were having asthma attacks, to about 22%. This was compared to those who were on albuterol alone who stayed at about 65%, so it was a pretty significant decrease in exacerbations.”

For additional information on the medication and its results, view the full interview posted above.

The quotes contained in this summary were edited for the purposes of clarity. Kraft has previously reported receiving grants from the National Institutes of Health, GlaxoSmithKline, Chiesi, AstraZeneca, and Genentech.